Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility assurance for an injectable drug, which is a high-risk product category. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. The specific product identified is Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in a clear glass injectable vial. The recall is initiated in connection with a recent FDA inspection.
The recall is due to observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the number of units recalled or the specific distribution locations beyond the manufacturer's address in Naperville, IL.
Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. for further instructions or a replacement. The recall is voluntary and is being conducted to ensure patient safety regarding the sterility of the compounded preparations.
The recalled product
- Product
- Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 08132014@35
- Exp 11/11/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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